NCT00995345已完成2 期
A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Asses the Safety and Efficacy of Once-Daily KRP-104 in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Alone.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 403
- 主要终点
- Change in HbA1c From Baseline (Week 0) to Week 24
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of KRP-104 on glycemic control in patients with type 2 diabetes inadequately controlled on metformin alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients meeting the following criteria at the screening visit (Visit 1) will be eligible to participate in the trial:
- •Signed written informed consent;
- •Males and females 18 to 75 years of age, inclusive;
- •Females of childbearing potential must agree to use 2 adequate forms of barrier method contraception (eg, latex condom AND intrauterine device or a diaphragm) to avoid pregnancy while in the study;
- •On a stable dose (Greater than or equal to 10 weeks at the same dose) of metformin monotherapy (Less than or equal to 1500 mg/day or maximum tolerated dose), have an HbA1c greater than or equal to 7.0% and less than or equal to 10.5%; or
- •On metformin (less than or equal to 1500 mg/day) and 1 other antidiabetic agent (excluding TZD, insulin, or incretin therapies [DPP-4 inhibitors and GLP-1 analogues]) and have an HbA1c greater than or equal to 6.8% and less than or equal to 10.0%; or
- •Not on antidiabetic therapy (for at least 3 months prior to Visit 1) or have not been on a stable dose of metformin monotherapy for 10 weeks and have an HbA1c greater than or equal to 8.0% and less than or equal to 11.0%.
排除标准
- •History of type 1 diabetes mellitus or history of diabetic ketoacidosis or persistent hypoglycemia;
- •History or presence of alcoholism or drug abuse within the 2 years prior to dosing;
- •Typical consumption of greater than or equal to 10 drinks of alcohol weekly;
- •Presence of any of the following conditions:
- •Significant renal impairment (glomerular filtration rate less than 60 mL/min);
- •Diabetic gastroparesis;
- •Active liver disease (other than asymptomatic nonalcoholic fatty liver disease), cirrhosis, or symptomatic gallbladder disease;
- •Fasting plasma glucose/blood glucose greater than 240 mg/dL (13.3 mmol/L) at Visit 3 (Week -2) (1 laboratory retest permitted);
- •Body mass index less than or equal to 20 kg/m2 and greater than or equal to 48 kg/m2;
- •Systolic blood pressure <100 mmHg or >160 mmHg and diastolic blood pressure <50 mmHg or >100 mmHg at Visit 3 (Note: medication to control blood pressure is allowed and should be optimized and stabilized prior to Visit 3);
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 X the upper limit of normal (ULN) (1 laboratory retest permitted);
- •Creatine phosphokinase (CPK) greater than 2 X the ULN (if not explained by muscular trauma or exercise) (1 laboratory retest permitted);
- •Serum creatinine >1.5 mg/dL for males (132.6 μmol/L) and 1.4 mg/dL for females (123.8 μmol/L);
- •Fasting triglycerides (TG) >600 mg/dL (6.78 mmol/L) at Visit 3 (Week -2) (Note: diet/exercise and lipid-lowering medication to control elevated TG is allowed; medications should be optimized and stabilized prior to Visit 3);
- •Treatment with pioglitazone or rosiglitazone within the previous 10 weeks (Visit 1); treatment with incretin therapy (DPP-4 inhibitors or GLP-1 analogues) within the previous 4 weeks (Visit 1);
- •Treatment with any type of insulin (ie, injected or inhaled) within the previous 3 months;
- •Must meet other laboratory and Medical History clinical criteria. Please contact recruitment center for referrals
研究组 & 干预措施
Dose 4: KRP-104 20/120mg
Experimental
Tablet, once-daily for 24 weeks (dose switch from 20 to 120 mg at week 12)
干预措施: KRP-104 (Drug)
Dose 1: KRP-104 40 mg
Experimental
Tablet, once-daily for 24 weeks
干预措施: KRP-104 (Drug)
Dose 2: KRP-104 80 mg
Experimental
Tablet, once-daily for 24 weeks
干预措施: KRP-104 (Drug)
Dose 3: KRP-104 100 mg
Experimental
Tablet, once-daily for 24 weeks
干预措施: KRP-104 (Drug)
Placebo
Placebo Comparator
Tablet, once-daily for 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change in HbA1c From Baseline (Week 0) to Week 24
时间窗: Week 24
Mean Change in HbA1c (%) from Baseline to Week 24 with LOCF, ITT population LS mean (SE)
次要结局
- Percentage of Patients Achieving HbA1c Less Than 7%(24 weeks)
- Percentage of Patients Requiring Rescue Therapy for Elevated Glucose(24 weeks of treatment.)
- Change in Body Weight(24 weeks)
研究者
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